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Idera Pharmaceuticals Shares Positive Results from Investigator-Sponsored Trial in Melanoma Patients at Amsterdam UMC

Idera Pharmaceuticals Shares Positive Results from Investigator-Sponsored Trial in Melanoma Patients at Amsterdam UMC

Idera Prescribed drugs, Inc.

– Enrollment Stopped Early for Efficacy –

EXTON, Pa., Might 17, 2022 (Globe NEWSWIRE) — Idera Pharmaceuticals, Inc. (“Idera,” “we,” and “our”) (Nasdaq: IDRA) nowadays shared positive interim final results from Amsterdam UMC, Vrije Universiteit Amsterdam, the Netherlands, regarding its investigator-sponsored demo, INTRIM 1, involving tilsotolimod, Idera’s synthetic Toll-like receptor 9 agonist. Centered on these results, the trial has been stopped early.

INTRIM 1 is a randomized, double-blind, placebo-managed Phase 2 demo amid clients with localized, excised melanoma (pathological tumor stage 3-4) with no regional metastases detected and no proof of distant metastasis. The trial involved a single, intradermal injection of 8 mg tilsotolimod or saline placebo offered at the primary tumor excision web-site, adopted by re-excision and sentinel lymph node (SLN) biopsy 7-10 days later on. Noting that there ended up much more clients with ulcerated lesions in the placebo arm when compared to the tilsotolimod arm, topline interim effects of the respective SLN-positivity fees confirmed a 70% decrease SLN+ rate amongst sufferers injected with tilsotolimod as compared to individuals injected with placebo the placebo SLN+ charge was in the mid-40%s. Statistical importance exceeded the pre-specified p-value of .008. Adverse reactions integrated injection site reactions, malaise, fever and flu-like signs or symptoms.

“This is an remarkable result from tilsotolimod, and we are delighted for the people and their households to whom it presents hope for the future,” claimed Vincent Milano, Idera’s Chief Govt Officer. “These effects, jointly with knowledge supporting tilsotolimod’s system of motion and encouraging safety profile from throughout the array of earlier pre-medical and medical get the job done, fortify the opportunity of tilsotolimod to offer you reward to patients with certain cancers. As a outcome, we strategy to actively go after a strategic partnership for tilsotolimod so that its full likely for clients may perhaps go on to be explored.”

This interim outcome validates beforehand reported final results from INTRIM 1 that confirmed immune activation, such as elevated frequencies of vital dendritic cells, in early examination by circulation cytometry of the SLN biopsies. The demo will proceed to relapse-free survival (RFS) and all round survival (OS) at 5 and 10 decades following SLN biopsy.

“Currently, there are constrained adjuvant treatment options available to make improvements to survival just after surgical excision of a major melanoma,” stated Prof. Tanja de Gruijl of Amsterdam UMC. “We are delighted with the outcomes we have witnessed in this analyze, which recommend that tilsotolimod administered at the excision web-site lowers the extent of tumor-beneficial lymph nodes and, if it increases total survival, gives early melanoma sufferers a likely new treatment selection.” Amsterdam UMC investigators approach to present the complete knowledge set at an approaching health-related meeting.

About Melanoma
Melanoma is a most cancers that begins in a variety of skin mobile called melanocytes. Though melanoma is the least frequent style of pores and skin most cancers, it has a weak prognosis when not detected and taken care of early. Early stages of melanoma are handled by eradicating, or excising, the tumor surgically. Even so, even immediately after surgical procedures, practically a single-3rd of all melanoma patients will expertise disorder recurrence and most relapses inevitably will development to metastatic illness. When regional lymphatic metastases are current, the 10-calendar year survival level is 68% – 24%. SLN biopsy is a beneficial prognostic software for the evaluation of melanoma relapse and mortality danger. Ulceration is affiliated with far more SLN positivity.

In several scenarios, further most cancers treatment method, referred to as adjuvant therapy, is provided soon after the key excision of the melanoma. The aim of adjuvant treatment is to reduce the threat of melanoma returning and potentially metastasizing. The adjuvant industry sizing for melanoma excision instances is more than 1 million cases globally and about 300,000 in the US yearly. As is the case in numerous forms of cancer, melanoma will become more hard to deal with after the ailment has distribute, or metastasized, further than the skin to other elements of the overall body.

About INTRIM 1
INTRIM 1 is a multi-middle investigator-sponsored trial executed by UMC Amsterdam among the clients with pT3-4 cN0M0 melanoma. The examine is a randomized, double-blind, placebo-managed Phase 2 trial of a one, intradermal injection of 8 mg tilsotolimod or of saline placebo provided at the principal tumor excision internet site 7-10 days prior to SLN biopsy.

INTRIM 1 is intended to examine the potential of tilsotolimod to induce loco-regional and systemic immune stimulation, and consequently, enhance survival among the targeted client inhabitants. Consequence actions of the trial involve the subsequent:

Though enrollment for the principal endpoint has been halted early as a result of the principal endpoint currently being satisfied, the research will continue on to its secondary endpoints. For more information on the INTRIM 1 demo, be sure to go to www.ClinicalTrials.gov (NCT04126876).

About Tilsotolimod (IMO-2125)
Tilsotolimod is an investigational, synthetic Toll-like receptor 9 agonist. Tilsotolimod has been revealed to promote both of those innate (Kind-I IFN, antigen presentation) and adaptive (T cells) immune activation and may possibly, in change, add to tumor suppression and regression. For much more information on tilsotolimod trials, please visit www.ClinicalTrials.gov.

About Idera Pharmaceuticals
Idera is targeted on the acquisition, progress, and best commercialization of drug candidates for exceptional condition indications characterised by tiny, very well-outlined patient populations with major unmet requirements. To discover far more about Idera, go to IderaPharma.com.

Ahead-Wanting Statements
This press launch contains forward-hunting statements inside the which means of Segment 27A of the Securities Act of 1933, as amended, and Segment 21E of the Securities Trade Act of 1934, as amended. All statements, other than statements of historic truth, provided or included in this press release, which includes statements with regards to the Company’s system, options, prospective clients, likely collaborations or licensing arrangements, improvement or commercialization of Idera’s portfolio property, medical trials and linked endpoints and the timing thereof, and the strategies and aims of management, are ahead-searching statements. The terms “thinks,” “anticipates,” “estimates,” “options,” “expects,” “intends,” “might,” “could,” “ought to,” “prospective,” “probably,” “initiatives,” “continue,” “will,” “schedule,” and “would” and similar expressions are meant to establish forward-hunting statements, despite the fact that not all ahead-searching statements incorporate these identifying terms. These ahead-hunting statements are predictions dependent on the Company’s existing expectations and projections about potential functions and various assumptions. Idera are unable to assurance that it will accomplish the plans, intentions, or anticipations disclosed in its forward-hunting statements and you need to not spot undue reliance on the Company’s forward-searching statements. These ahead-looking statements entail acknowledged and not known threats, uncertainties, and other variables, which may well be past Idera’s command, and which may possibly bring about the precise success, performance, or achievements of the Business to vary materially from potential outcomes, efficiency, or achievements expressed or implied by such forward-on the lookout statements. There are a range of important elements that could cause Idera’s real outcomes to differ materially from individuals indicated or implied by its forward-seeking statements including, devoid of limitation: irrespective of whether the Company’s dollars assets will be ample to fund the Company’s continuing operations and the even further advancement of the Company’s programs no matter whether topline benefits from a scientific trial will be predictive of the closing benefits of the demo whether final results obtained in preclinical experiments and medical trials will be indicative of the outcomes that will be created in upcoming scientific trials, which includes in clinical trials in various disorder indications whether products centered on Idera’s technological innovation will advance into or via the medical trial procedure when predicted or at all or warrant submission for regulatory acceptance whether or not such merchandise will acquire approval from the U.S. Foodstuff and Drug Administration or equal overseas regulatory organizations whether, if the Firm’s products and solutions obtain acceptance, they will be properly dispersed and promoted whether or not the Firm’s collaborations will be successful the Company’s capacity to fulfill the demands for continued listing of our frequent stock on the Nasdaq Cash Marketplace and the affect of community overall health crises, which includes the coronavirus (COVID-19) pandemic. All forward-hunting statements provided in this push launch are produced as of the day hereof and are expressly certified in their entirety by this cautionary see, which includes, with no limitation, those risks and uncertainties described in the Company’s Once-a-year Report on Kind 10-K for the yr finished December 31, 2021, and if not in the Company’s filings and reviews submitted with Securities and Exchange Commission. When Idera may elect to do so at some place in the potential, the Company does not assume any obligation to update any ahead-searching statements and it disclaims any intention or obligation to update or revise any forward-hunting assertion, no matter whether as a outcome of new data, foreseeable future situations, or or else, apart from as may be expected by law.

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